Erectile Dysfunction Following Radical ProstatectomyNCT04491773
Study of Retinal and Choriocapillary Vascular Changes in Patients Undergoing Tadalafil 20mg for More Than 6 Months
An observational study of Erectile Dysfunction Following Radical Prostatectomy, run by Federico II University at 1 site in Italy.
Trial summary
This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg for more than 6 months, using optical coherence tomography angiography. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- Tadalafil 20 MG
- Type of treatment
- Pill or oral medicine
- How many people
- 54 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2019to 30 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The participans were older than 45 years with diagnosis of erectile dysfunction due to surgery of radical prostatectomy. They did not receive previous treatment before Tadalafil. They did not present any ophthalmological disease, diabetes, heart diseases and hypertension.
Who may be able to join
- age older than 45 years
- diagnosis of erectile dysfunction due to surgery of radical prostatectomy
- treatment-naïve with Tadalafil for erectile dysfunction for more than 6 months
- absence of diabetes, heart diseases, hypertension
- absence of drug intake
- absence of vitreoretinal, vascular retinal diseases
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- absence of previous ocular surgery and congenital eye diseases.
- absence of errors of refraction
- absence of lens opacities
- absence of low-quality OCT and OCTA images
Who cannot join
- age younger than 45 years
- diagnosis of erectile dysfunction due to other causes
- previous treatments before Tadalafil for erectile dysfunction
- presence of diabetes, heart diseases, hypertension
- drug intake
- vitreoretinal and vascular retinal diseases
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- previous ocular surgery and congenital eye diseases
- errors of refraction
- lens opacities
- low-quality OCT and OCTA images
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Retinal and Choriocapillary Vascular Changes Using Optical Coherence Tomography Angiography in Patients Undergoing Tadalafil 20mg on Alternative Days for More Than 6 Months: a Single-centre Prospective-control
This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg for more than 6 months, using optical coherence tomography angiography.
Read the detailed description
Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood flow to the penis thus promoting the erection.
This drug represents an treatment for erectile dysfunction in patients after radical prostatectomy.
The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.
The study evaluates the changes in optical coherence tomography angiography features after the somministration of Tadalafil 20 mg orally for more than 6 months.
- Being tested
- Tadalafil 20 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 20 MGDrug
Also called Cialis
To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing Tadalafil | Patients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for more than 6 months Receives: Drug: Tadalafil 20 MG | |
| Control Group | Healthy controls without previous surgery of radical prostatectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months
Changes in retinal and choriocapillary vessel density in patients after radical prostatectomy, undergoing Tadalafil 20 mg orally on alternate days for more than 6 months, using optical coherence tomography angiography.
The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density
Measured: More than 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Nov 2019
- Primary completion25 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
- Investigators
- Gilda Cennamo, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491773
- Sponsor's protocol ID
- 1516/19
- Status last verified
- Nov 2019
- First submitted
- 25 Jul 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Retinal and Choriocapillary Vascular Changes Using Optical Coherence Tomography Angiography in Patients Undergoing Tadalafil 20mg on Alternative Days for More Than 6 Months: a Single-centre Prospective-control
- ClinicalTrials.gov ID
- NCT04491773
- Acronym / sponsor ID
- 1516/19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the retinal and choriocapillary vascular features in patients under the effects of Tadalafil 20mg for more than 6 months, using optical coherence tomography angiography.
Detailed description
Tadalafil is a an inhibitor of the enzyme phosphodiesterase and it works by increasing blood flow to the penis thus promoting the erection.
This drug represents an treatment for erectile dysfunction in patients after radical prostatectomy.
The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features.
The study evaluates the changes in optical coherence tomography angiography features after the somministration of Tadalafil 20 mg orally for more than 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Tadalafil | – | Drug: Tadalafil 20 MGPatients after radical prostatectomy, undergoing Tadalafil 20 mg orally, on alternative days, for more than 6 months |
| Control Group | – | –Healthy controls without previous surgery of radical prostatectomy. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participans were older than 45 years with diagnosis of erectile dysfunction due to surgery of radical prostatectomy. They did not receive previous treatment before Tadalafil. They did not present any ophthalmological disease, diabetes, heart diseases and hypertension.
Key inclusion criteria (10 listed)
- age older than 45 years
- diagnosis of erectile dysfunction due to surgery of radical prostatectomy
- treatment-naïve with Tadalafil for erectile dysfunction for more than 6 months
- absence of diabetes, heart diseases, hypertension
- absence of drug intake
Key exclusion criteria (10 listed)
- age younger than 45 years
- diagnosis of erectile dysfunction due to other causes
- previous treatments before Tadalafil for erectile dysfunction
- presence of diabetes, heart diseases, hypertension
- drug intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tadalafil 20 MGAlso: CialisTo study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months. | Drug | Patients undergoing Tadalafil |
Primary outcome
The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months
Time frame: More than 6 months
Changes in retinal and choriocapillary vessel density in patients after radical prostatectomy, undergoing Tadalafil 20 mg orally on alternate days for more than 6 months, using optical coherence tomography angiography. The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilda Cennamo principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction Following Radical Prostatectomy, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurements of retinal and choriocapillary vessel density in patients undergoing Tadalafil for more than 6 months (time frame: More than 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.